Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a
biopharmaceutical company committed to improving patient lives by
manufacturing high quality products for biotechnology and
pharmaceutical companies and advancing its proprietary R&D
pipeline, today announced that the National Comprehensive Cancer
Network® (NCCN®) Oncology Research Program (ORP) has awarded three
grants to investigators to support research of bavituximab in
combination with other therapeutics for the treatment of
glioblastoma, head and neck cancer, and hepatocellular carcinoma.
NCCN, a not-for-profit alliance of 27 of the
world's leading cancer centers devoted to patient care, research,
and education, is dedicated to improving the quality,
effectiveness, and efficiency of cancer care so that patients can
live better lives. Funding for the three
investigator-initiated clinical studies will take place through a
$2 million research grant made by Peregrine to NCCN’s ORP.
NCCN will be responsible for oversight and monitoring of the
clinical studies through the research grant. It is expected
that the selected trials will be initiated in early 2017.
“NCCN is excited to initiate three studies by
accomplished investigators at NCCN Member Institutions that will
explore the effect of this novel immunotherapy in three different
cancers with significant unmet need,” said Robert C. Young, MD,
Interim Vice President, NCCN ORP.
The following NCCN-affiliated researchers were recipients of the
grant awards:
- Jessica Frakes, MD, Moffitt Cancer Center, “A Phase I Trial of
Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy
(SBRT) for Unresectable Hepatitis C Associated Hepatocellular
Carcinoma”
- Elizabeth Gerstner, MD, Massachusetts General Hospital Cancer
Center, “Phase I/II Clinical Trial of Bavituximab with Radiation
and Temozolomide for Patients with Newly Diagnosed Glioblastoma”
- Ranee Mehra, MD, The Sidney Kimmel Comprehensive Cancer Center
at Johns Hopkins, “Phase II Study of Pembrolizumab and Bavituximab
for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the
Head and Neck”
“Our collaboration with NCCN provides the unique
opportunity to support the group’s highly-regarded research
institutions and advance our understanding of the potential role of
bavituximab in the treatment of various cancers. With this in mind,
we were very pleased by the level of interest shown in bavituximab
from the NCCN community and are grateful to all those who submitted
their projects for rigorous evaluation by the ORP scientific review
committee,” said Joseph Shan, MPH, vice president, clinical and
regulatory affairs of Peregrine. “We’d like to extend our
congratulations to the three investigators who were selected for
their unique and innovative concepts. These studies align
with our development strategy for bavituximab which is currently
focused on small, early stage clinical trials evaluating the drug
in combination with other cancer treatments. Collaborators such as
NCCN play a central role in this strategy and we look forward to
integrating the valuable clinical data generated by these
investigators to expand our knowledge regarding bavituximab-focused
cancer treatment combinations.”
Bavituximab is an investigational chimeric
monoclonal antibody that targets phosphatidylserine (PS). Signals
from PS inhibit the ability of immune cells to recognize and fight
tumors. Bavituximab is believed to override PS mediated
immunosuppressive signaling by blocking the engagement of PS with
its receptors as well as by sending an alternate immune activating
signal. PS targeting antibodies have been shown to shift the
functions of immune cells in tumors, resulting in multiple signs of
immune activation and anti-tumor immune responses.
About Peregrine Pharmaceuticals,
Inc.Peregrine Pharmaceuticals, Inc. is a biopharmaceutical
company committed to improving the lives of patients by delivering
high quality pharmaceutical products through its contract
development and manufacturing organization (CDMO) services and
through advancing and licensing its investigational immunotherapy
and related products. Peregrine's in-house CDMO services,
including cGMP manufacturing and development capabilities, are
provided through its wholly-owned subsidiary Avid Bioservices, Inc.
(www.avidbio.com), which provides development and biomanufacturing
services for both Peregrine and third-party customers. The
company is also working to evaluate its lead immunotherapy
candidate, bavituximab, in combination with immune stimulating
therapies for the treatment of various cancers, and developing its
proprietary exosome technology for the detection and monitoring of
cancer. For more information, please visit
www.peregrineinc.com.
About the National Comprehensive Cancer
NetworkThe National Comprehensive Cancer Network® (NCCN®),
a not-for-profit alliance of 27 of the world’s leading cancer
centers devoted to patient care, research, and education, is
dedicated to improving the quality, effectiveness, and efficiency
of cancer care so that patients can live better lives. Through the
leadership and expertise of clinical professionals at NCCN Member
Institutions, NCCN develops resources that present valuable
information to the numerous stakeholders in the health care
delivery system. As the arbiter of high-quality cancer care, NCCN
promotes the importance of continuous quality improvement and
recognizes the significance of creating clinical practice
guidelines appropriate for use by patients, clinicians, and other
health care decision-makers.
The NCCN Member Institutions are: Fred &
Pamela Buffett Cancer Center, Omaha, NE; Case Comprehensive Cancer
Center/University Hospitals Seidman Cancer Center and Cleveland
Clinic Taussig Cancer Institute, Cleveland, OH; City of Hope
Comprehensive Cancer Center, Los Angeles, CA; Dana-Farber/Brigham
and Women’s Cancer Center | Massachusetts General Hospital Cancer
Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase
Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the
University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer
Research Center/Seattle Cancer Care Alliance, Seattle, WA; The
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,
Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of
Northwestern University, Chicago, IL; Mayo Clinic Cancer Center,
Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN;
Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt
Cancer Center, Tampa, FL; The Ohio State University Comprehensive
Cancer Center - James Cancer Hospital and Solove Research
Institute, Columbus, OH; Roswell Park Cancer Institute, Buffalo,
NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington
University School of Medicine, St. Louis, MO; St. Jude Children’s
Research Hospital/The University of Tennessee Health Science
Center, Memphis, TN; Stanford Cancer Institute, Stanford, CA;
University of Alabama at Birmingham Comprehensive Cancer Center,
Birmingham, AL; UC San Diego Moores Cancer Center, La Jolla, CA;
UCSF Helen Diller Family Comprehensive Cancer Center, San
Francisco, CA; University of Colorado Cancer Center, Aurora, CO;
University of Michigan Comprehensive Cancer Center, Ann Arbor, MI;
The University of Texas MD Anderson Cancer Center, Houston, TX;
University of Wisconsin Carbone Cancer Center, Madison, WI;
Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer
Center/Smilow Cancer Hospital, New Haven, CT.
Clinicians, visit NCCN.org. Patients and
caregivers, visit NCCN.org/patients. Media, visit
NCCN.org/news.
Safe Harbor Statement:
Statements in this press release which are not purely historical,
including statements regarding Peregrine Pharmaceuticals'
intentions, hopes, beliefs, expectations, representations,
projections, plans or predictions of the future are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. The forward-looking statements involve risks
and uncertainties including, but not limited to, the risk that one
or more of the investigator-initiated clinical studies may
experience enrollment delays, the risk that data from one or more
of the investigator-initiated clinical studies does not support the
company’s current understanding of the potential role of
bavituximab in the treatment of various cancers or is otherwise
inconclusive, and the risk that on-going analysis of SUNRISE trial
data, bio-specimen samples and patient characteristics may not
identify any subgroup that received clinical benefit from the
addition of bavituximab. The company's actual results could differ
materially from those in any such forward-looking statements.
Factors that could cause actual results to differ materially
include, but are not limited to, uncertainties associated with
completing preclinical and clinical trials for our technologies;
the early stage of product development; the significant costs to
develop our products as all of our products are currently in
development, preclinical studies or clinical trials; obtaining
additional financing to support our operations and the development
of our products; obtaining regulatory approval for our
technologies; anticipated timing of regulatory filings and the
potential success in gaining regulatory approval and complying with
governmental regulations applicable to our business. Our business
could be affected by a number of other factors, including the risk
factors listed from time to time in our reports filed with the
Securities and Exchange Commission including, but not limited to,
our annual report on Form 10-K for the fiscal year ended April 30,
2016 as well as any updates to these risk factors filed from time
to time in the company's other filings with the Securities and
Exchange Commission. The company cautions investors not to place
undue reliance on the forward-looking statements contained in this
press release. Peregrine Pharmaceuticals, Inc. disclaims any
obligation, and does not undertake to update or revise any
forward-looking statements in this press release.
Contacts:
Jay Carlson
Peregrine Pharmaceuticals, Inc.
(800) 987-8256
info@peregrineinc.com
Stephanie Diaz (Investors)
Vida Strategic Partners
415-675-7401
sdiaz@vidasp.com
Tim Brons (Media)
Vida Strategic Partners
415-675-7402
tbrons@vidasp.com
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